In the Q4 earnings release, Evelo Biosciences Inc (NASDAQ:EVLO) shared results from an ongoing Phase 1 single-center trial in healthy volunteers that showed that a capsule with an improved release profile could deliver EDP1815 higher up in the small intestine.
- 88% (15 out of 17) of the human volunteers showed EDP1815 released in the upper part of the small intestine.
- Evelo plans to evaluate this faster release capsule in an upcoming clinical trial.
- Related: Evelo Biosciences' Psoriasis Candidate Shows Reductions In Inflammatory Cytokines.
- Also, the European Medicines Agency (EMA) agreed to Evelo's pediatric investigation plan (PIP) for EDP1815 in psoriasis that allows to include patients 12–17 years old in Phase 3 trials, conduct a single trial in patients 2–5 years old and 6-11 years old.
- PIP also allows developing a pediatric formulation suitable for administration to patients 2 -11 years old.
- The EMA also confirmed that juvenile toxicity studies are not required for EDP1815 and granted the Company a waiver from studying EDP1815 in patients less than two years old.
- Evelo closed 2021 with cash and cash equivalents of $68.4 million.
- Price Action: EVLO shares are up 16.2% at $3.80 during the market session on the last check Thursday.
